Safyral Side Effects

Generic name: drospirenone / ethinyl estradiol / levomefolate calcium

Note: This document contains side effect information about drospirenone / ethinyl estradiol / levomefolate calcium. Some of the dosage forms listed on this page may not apply to the brand name Safyral.

Some side effects of Safyral may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to drospirenone / ethinyl estradiol / levomefolate calcium: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking drospirenone / ethinyl estradiol / levomefolate calcium: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using birth control pills and call your doctor at once if you have a serious side effect such as:

• sudden numbness or weakness, sudden and severe headache, confusion, problems with vision or speech;

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

• sudden cough, wheezing, rapid breathing, coughing up blood;

• pain, swelling, warmth, or redness in one or both legs;

• a change in the pattern or severity of migraine headaches;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• swelling in your hands, ankles, or feet;

• a breast lump; or

• symptoms of depression (sleep problems, weakness, tired feeling, mood changes).

Less serious side effects of drospirenone / ethinyl estradiol / levomefolate calcium may include:

• mild nausea (especially when you first start taking this medicine), vomiting, bloating, stomach cramps;

• breast tenderness or swelling, nipple discharge;

• freckles or darkening of facial skin, increased hair growth, loss of scalp hair;

• problems with contact lenses; or

• vaginal itching or discharge, changes in your menstrual periods.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to drospirenone / ethinyl estradiol / levomefolate calcium: oral tablet

Cardiovascular

Cardiovascular side effects have included hypertension, arterial or deep venous thrombotic events, strokes, and myocardial infarctions.

Genitourinary

Genitourinary side effects have included breast tenderness, decreased libido, unscheduled (breakthrough or intracyclic) bleeding and spotting.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, and inflammatory bowel disease.

Hepatic

Hepatic side effects have included jaundice, cholestasis and hepatic adenomas.

Metabolic

Metabolic side effects have included gallbladder disease, liver function disturbances, liver tumors, hyperkalemia, hypertriglyceridemia, changes in glucose tolerance, and effect on peripheral insulin resistance (including diabetes mellitus).

Nervous system

Nervous system side effects have included an increase in frequency or severity of migraine headaches.

Ocular

Ocular side effects have included loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions.

Psychiatric

Psychiatric side effects have included irritability, depression and affect lability.

Oncologic

Oncologic side effects have included carcinoma of the breasts and reproductive organs.

Musculoskeletal

Musculoskeletal side effects have included systemic lupus erythematosus.

Dermatologic

Dermatologic side effects have included chloasma, angioedema, erythema nodosum, and erythema multiforme.

Hypersensitivity

Hypersensitivity side effects have included anaphylactic reaction.

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